29 July 2014 - 29 July 2014 - Swiss Roche (VTX:ROG) said Tuesday that Gazyvaro (obinutuzumab) had been cleared by the European Commission (EC) in combination with chlorambucil to treat patients with priorly untreated chronic lymphocytic leukemia who have comorbidities making them unsuitable for a full-dose fludarabine-based therapy.

The authorisation is based on data of the CLL11 trial, carried out in partnership with German CLL Study Group. The trial demonstrated that Gazyvaro in combination with chlorambucil achieved its primary goal by significantly decreasing the risk of disease worsening or death by 61% versus MabThera/Rituxan in combination with chlorambucil (progression free survival; PFS). Median PFS for patients taking Gazyvaro was 26.7 months versus 15.2 months for those receiving MabThera/Rituxan (HR 0.39, CI 0.31-0.49, p